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Changes in Sexual Function Following Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00670098
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : October 22, 2015
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:

The main purposes of the study are to compare changes in sexual function, changes in sex hormones, and changes in body image and marital satisfaction at 12, 24, 36 and 48 months postoperatively in two groups: individuals who undergo a bariatric surgical procedure and extremely obese individuals with similar obesity-related comorbidities who do not seek surgery (treatment comparison group).

The mechanisms by which extreme obesity affects sexual functioning have received little attention. Recent epidemiologic studies suggest that obesity and physical inactivity are independently related to the likelihood of developing sexual dysfunction over time. For example, men with a BMI greater than 29 kg/m2 have a 30% greater risk of developing erectile dysfunction and up to 50 % of ED cases can be attributed to hypertension and cardiovascular disease, both commonly associated with obesity. Many treatments for hypertension have also been shown to interfere with sexual function.

Changes in sex hormones with increasing BMI have not received much attention either. Obesity has been associated with decreases in testosterone and sex hormone binding globulin for men and increases in testosterone and estrogen for women. Several studies have shown improvement in sex hormone levels in both men and women following weight loss. Sexual functioning has never been assessed in association with weight loss and whether through improvements in body image, sex hormones, or obesity related comorbidities, bariatric surgery may have a profound effect on sexual functioning.

Dr. Ray Rosen, the Principal investigator for this sub study, has conducted a previous investigation focused on sexual functioning after weight loss in a behavioral weight loss program. Specifically, he looked at short and long term sexual function outcomes associated with Type-2 diabetes. His previous work in this area has shown that patients are willing to participate in studies of sexual function.

The Psychosocial Changes study assesses sexual function in two ways. Participants first fill out a packet of questionnaires covering topics related to depression, quality of life, body image, and marital and sexual functioning. They also give a blood sample in order for us to assess levels of sex hormones including testosterone, luteinizing hormone, estradiol, follicle stimulating hormone, and others.


Condition or disease Intervention/treatment Phase
Obesity Procedure: Bariatric surgery Behavioral: lifestyle intervention (behavioral weight loss) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Psychosocial Changes Associated With Weight Loss
Study Start Date : August 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Procedure: Bariatric surgery
patients receive either gastric bypass or lap-band
Experimental: 2 Behavioral: lifestyle intervention (behavioral weight loss)
participants attend biweekly weight loss counseling group sessions


Outcome Measures
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Primary Outcome Measures :
  1. Sexual functioning as measured by the International Index for Erectile Dysfunction (for men) and the Female Sexual Function Inventory (for women) [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. sex hormones [ Time Frame: 48 months ]
  2. body image (Body Shape Questionnaire and The Body Image Quality of Life Questionnaire) [ Time Frame: 48 months ]
  3. relationship functioning (Dyadic Adjustment Scale) [ Time Frame: 48 months ]
  4. quality of life (Impact of Weight on Quality of Life questionnaire and Medical Short Form Survey) [ Time Frame: 48 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Age: Patients must be between 18 and 65 years of age.

    • Gender: Both women and men are eligible to participate.
    • Ethnicity and Race: Individuals from all ethnic and racial groups will be invited to participate.
    • Body Mass Index: 40 to 60 kg/m2 (or of > 35 kg/m2 in the presence of co-morbid medical conditions).
    • Ambulation: Patients must be ambulatory, given the frequent number of assessments (and difficult arranging transportation for non-ambulatory individuals
    • Competent: The patient must be able to communicate with the investigator and be legally competent, provide written informed consent.

Exclusion Criteria:

  • • Any major illnesses that the surgical team believes present too great a risk for surgery. These include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.

    • Evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that significantly interferes with daily living and functioning.
    • Use of medications known to significantly increase body weight, such as systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and anti-psychotic agents (The use of selective serotonin re-uptake inhibitors (SSRIs) will not be excluded because of their widespread use and lesser effect on body weight.)
    • Patients who are not in an ongoing romantic relationship
    • Any current (past 12 months) substance abuse or dependence disorder.
    • Pregnancy or lactation (Those who are pregnant do not undergo bariatric surgery. In addition, the hormone changes induced by pregnancy are known to interfere with the hormones examined in this study, confounding the findings. Participants who become pregnant while in this study will be withdrawn from the study.)
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00670098    
Other Study ID Numbers: DK72452
R01DK072452 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2008    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: November 2011